NCT00833716

Brief Summary

This trial is conducted in the United States of America (USA). The aim of this clinical trial is to investigate how different degrees of renal impairment (mild, moderate, severe and end-stage renal disease) affect the pharmacokinetics of NN9535.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P75+ for phase_1 diabetes

Timeline
Completed

Started Feb 2009

Longer than P75 for phase_1 diabetes

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 2, 2009

Completed
Same day until next milestone

Study Start

First participant enrolled

February 2, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2010

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

1.5 years

First QC Date

January 29, 2009

Last Update Submit

March 31, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2Renal Impairment

Outcome Measures

Primary Outcomes (1)

  • AUC of NN9535

    at 21 days

Secondary Outcomes (1)

  • Laboratory safety, adverse events

    at 21 days

Study Arms (1)

A

EXPERIMENTAL
Drug: semaglutide

Interventions

semaglutideDRUG

10 mg/mL of semaglutide solution for s.c. injection, single dose

Also known as: NN9535
A

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
  • Subjects meeting the pre-defined GFR (glomerular filtration rate) criteria (estimated by the Cockcroft \& Gault formula) for any of the renal function groups
  • Body Mass Index (BMI) equal to or less than 40kg/m2

You may not qualify if:

  • Known or suspected allergy to trial product(s) or related products
  • Renal transplanted patients
  • Certain cardiac problems (heart failure, unstable angina, MI (myocardial infarction) within the last 3 months)
  • Known current hepatic dysfunction or severe hepatic disease during the last 12 months
  • Female of childbearing potential/breast feeding
  • History of alcoholism or drug abuse
  • Blood donation during the last 8 weeks prior to the study
  • Past or current history of pancreatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Novo Nordisk Investigational Site

Miami, Florida, 33014, United States

Location

Novo Nordisk Investigational Site

Orlando, Florida, 32806, United States

Location

Novo Nordisk Investigational Site

Knoxville, Tennessee, 37920, United States

Location

Related Publications (2)

  • Marbury T, Flint A, Segel S, Lindegaard M, Lasseter K. Pharmacokinetics and tolerability of semaglutide, a once-weekly human GLP-1 analog, in subjects with and without renal impairment. Diabetes 2014; 63 (Suppl 1): A260 (abstract 1010-P)

    RESULT

  • Marbury TC, Flint A, Jacobsen JB, Derving Karsbol J, Lasseter K. Pharmacokinetics and Tolerability of a Single Dose of Semaglutide, a Human Glucagon-Like Peptide-1 Analog, in Subjects With and Without Renal Impairment. Clin Pharmacokinet. 2017 Nov;56(11):1381-1390. doi: 10.1007/s40262-017-0528-2.

    PMID: 28349386RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2Renal Insufficiency

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2009

First Posted

February 2, 2009

Study Start

February 2, 2009

Primary Completion

July 26, 2010

Study Completion

July 26, 2010

Last Updated

April 4, 2017

Record last verified: 2017-03

Locations

US(3)